FDA Approves New Drug to Fight Advanced Prostate Cancer

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug
Administration announced Wednesday that it has approved a drug to
help men with advanced prostate cancer whose disease has spread to
the bones.

The drug, Xofigo, is targeted to patients with late-stage,
metastatic disease that has spread to the bones but not to other
organs, the FDA said in a news release. It is meant for patients
who have already undergone surgery and/or drug therapies such as
hormone-based treatments.

The FDA said Xofigo, marketed by Wayne, N.J.-based Bayer
Pharmaceuticals, was approved more than three months ahead of the
original August 2013 deadline the agency had set for a complete
review. Instead, the drug was reviewed under the agency's
"priority" review program, designated for medicines that appear
safe and effective in a context where no good alternative therapy
exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic
prostate cancer that was resistant to hormonal therapy and had
spread to the bones, men on Xofigo survived a median of 14 months
compared to a little over 11 months for men taking a placebo. Side
effects from Xofigo included nausea, diarrhea, vomiting and
swelling of the legs and feet. Low levels of red and white blood
cells, as well as platelets, were also reported among some patients
taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug
approved by the FDA in the past year that demonstrates an ability
to extend the survival of men with metastatic prostate cancer." The
other drug, Xtandi, was approved by the FDA last August for men
with hormone treatment-resistant prostate cancers that have spread
or recurred, and who had previously been treated with the drug
docetaxel.

According to the American Cancer Society, prostate cancer
remains the leading cancer type among men outside of skin cancer,
and about one man in every six will develop the illness during his
lifetime. Caught early, it is often curable. About 239,000 new
cases of prostate cancer are diagnosed among American men each
year, and nearly 30,000 men die from the disease annually.

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